FDA applicant
Khi, Inc.
FDA records 4 decisions for Khi, Inc. (Mchenry, IL) from 1980 to 1983: 4 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and CAI (Circuit, Breathing (W Connector, Adaptor, Y…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Khi, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Khi, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Khi, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report